Granisetron Hydrochloride Oral Suspension
Granisetron Hydrochloride Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled content of granisetron hydrochloride (C18H24N4O·HCl). Prepare Granisetron Hydrochloride Oral Suspension (0.056 mg/mL) equivalent to 0.05 mg of Granisetron per mL as follows (see Pharmaceutical CompoundingNonsterile Preparations 795).
Calculate the required quantity of each ingredient for the total amount to be prepared. If using tablets, place the required number of tablets in a suitable mortar, and comminute the tablets to a fine powder with a pestle, or add Granisetron Hydrochloride powder. Add the Vehicle in small portions, and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a Granisetron Hydrochloride suspension that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough Vehicle to bring to final volume, and mix well.
Mobile phase: Acetonitrile and 50 mM monobasic sodium dihydrogen phosphate (3:17). Adjust with phosphoric acid to a pH of 7.0. Make adjustments if necessary (see Chromatography 621, System Suitability.)
Standard stock solution: 1.0 mg/mL USP Granisetron Hydrochloride RS
Standard solution: Transfer 2.5 mL of Standard stock solution to a 100-mL volumetric flask, and dilute with Mobile phase to volume to obtain a solution containing 25 µg/mL of granisetron hydrochloride.
Sample solution: Shake the Oral Suspension thoroughly by hand. Pipet 5.0 mL into a 10-mL volumetric flask. Dilute with Mobile phase to volume, and mix to obtain a nominal concentration of 25 µg of granisetron hydrochloride/mL.
Detector: UV 300 nm
Column: 4.6-mm × 15-cm; 5-µm packing L10
Flow rate: 1.0 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe retention time of the granisetron peak is 7.0 min. ]
Relative standard deviation: NMT 2.0% for the replicate injections
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of C18H24N4O·HCl in the volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0%
• pH 791: 4.04.5
• Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature or controlled cold temperature.
• Labeling: Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at controlled room temperature or when stored at controlled cold temperature
• USP Reference Standards 11
USP Granisetron Hydrochloride RS
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3375Pharmacopeial Forum: Volume No. 34(6) Page 1454